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<eudamedExport entity="devices">
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    <udiDi>05056682200707</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM500GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:42.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200684</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM150GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:41.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200677</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM50GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:41.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200660</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Thirty:30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THIRTY30OIN125GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:40.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200653</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Thirty30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THIRTY30OIN500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:39.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200646</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Emulsifying Ointment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMULSIOINT500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:38.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200639</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Fifty:50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIFTY50OINT250GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:37.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200622</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Fifty:50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIFTY50OINT500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:36.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200615</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Aquasoothe 2%</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUA2CREAM500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:35.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200608</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Aquasoothe 1%</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUA1CREAM500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:34.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200110</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX15GMAR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:32.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200103</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX6GM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:31.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200042</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX6GMAR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:30.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060254920214</udiDi>
    <basicUdiDi>506025492EmollientsP3</basicUdiDi>
    <tradeName>Aquasoothe 1% 100g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022280</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AQUA1CREAM100GRAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:50:11.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>07392222170405</udiDi>
    <basicUdiDi>506001888DNTKREPAIR001ZN</basicUdiDi>
    <tradeName>EKULF Tooth Repair Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:20:35.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>07392222170504</udiDi>
    <basicUdiDi>506001888DNTKGUARD001RS</basicUdiDi>
    <tradeName>EKULF NightGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:20:35.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09333279000046</udiDi>
    <basicUdiDi>9333279FLEXINOZER</basicUdiDi>
    <tradeName>Flexi Nozzles (Long)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENT Technologies Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000050290</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T07:07:15.780Z</lastUpdated>
  </row>
</eudamedExport>